Kornimate/medical-research-clean huggingface dataset:
study evaluating denosumab on bone and vascular metabolism in osteoporotic chronic kidney disease

Conditions: Female With Osteoporosis and Chronic Kidney Disease

Summary: aim of this study is to evaluate in a population of old osteoporotic chronic kidney disease females the effect of denosumab: * on bone mineral density (femoral t-score) at 24 months * on bone mineral density evolution (femoral t-score) after 24 months of follow-up * on bone mineral density evolution (lumbar t-score) after 24 months of follow-up * on coronary and abdominal aorta calcification scores evolution after 24 months of follow-up * on parameters of bone remodelling (opg, rankl, sclerostin, dkk-1), of mineral and calcium metabolism (fgf23 ct, klotho, pth, 25(oh) vitamin d3, phosphorus, calcium, bone alklaline phosphatase, osteocalcin, ctx), of inflammation (crp) after 24 months of follow-up * on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up * the tolerance after 24 months of follow-up

aim of this study is to evaluate in a population of old osteoporotic chronic kidney disease females the effect of denosumab: * on bone mineral density (femoral t-score) (by bone densitometry) at 24 months * on bone mineral density evolution (femoral t-score) (by bone densitometry) after 24 months of follow-up * on bone mineral density evolution (lumbar t-score) (by bone densitometry) after 24 months of follow-up * on coronary and abdominal aorta calcification scores evolution (by multiple detector computed tomography and plain abdominal x-ray) after 24 months of follow-up * on parameters of bone remodelling (opg, rankl, sclerostin, dkk-1), of mineral and calcium metabolism (fgf23 ct, klotho, pth, 25(oh) vitamin d3, phosphorus, calcium, bone alklaline phosphatase, osteocalcin, ctx), of inflammation (crp) after 24 months of follow-up * on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up * the tolerance after 24 months of follow-up

Eligibility criteria:
inclusion criteria: * patient of 65 years or older * chronic kidney disease stage 5 patient, hemodialyzed with extracorporeal treatment for at least 3 months * patient with osteoporosis (history of bone fracture or t-scoring \< -2.5 sd) * pth levels in the serum in agreement with the kdigo guidelines, in the absence of treatment with cinacalcet. exclusion criteria: * cinacalcet treatment * calcium parameters (pth, 25(oh) vitamin d3, calcium) outside the kdigo guidelines * suspicion of lower bone remodeling * hypersensibility to active substance or one of excipients of denosumab * patient with a cancer or myeloma * patient with severe heaptic cytolysis * patients with severe teeth problems * patient positive for hiv * patient involved in another biomedical research * vulnerable patients (protected by the law, under guardianship, deprived of freedom)

Keywords: osteoporosis chronic kidney disease anti-rank ligand antibody bone mineral density vascular calcifications
achieve grx registry

Conditions: Peripheral Arterial Disease; Peripheral Vascular Diseases; Renal Artery Disease; Carotid Artery Diseases

Summary: this study will evaluate real-world performance of the corpath grx system in peripheral vascular interventions.

this is a prospective, single-arm, open-label, multi-center registry of the corpath grx system to evaluate its real-world performance during peripheral vascular interventions.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. subject has a clinical indication for peripheral vascular intervention (pvi). 3. subject is deemed appropriate for robotic-assisted pvi. 4. the subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. 5. individual monitoring of radiation dose, using the pocket dosimeter, was initiated at start of procedure. exclusion criteria: 1. failure/inability/unwillingness to provide informed consent. 2. the investigator determines the subject or the peripheral anatomy is not suitable for ro-botic-assisted pvi. 3. women who are pregnant.
effects of wearable sensor-based interactive cognitive-motor training in older adults.

Conditions: Cognitive Decline, Mild; Cognition Disorders in Old Age; Subjective Memory Decline

Summary: * based on research showing that cognitive-motor training programs help improve cognition in older adults with mild cognitive impairment, this program uses an interactive system to combine cognitive training with exercise. * the interactive system consists of wearable sensors and has the advantage of cognitive training without space constraints, and the cognitive training program consists of a total of five developed cognitive training games. * the program is expected to improve the cognitive abilities of the elderly and improve their physical abilities.

the proposed study will conduct a randomized controlled trial to compare the effects of a cognitive-motor training program using a wearable sensor-based interactive system on the cognitive and physical abilities of older adults in the community. study participants will be randomly assigned to receive one of two interventions: (a) motor-cognitive training (b) cognitive training. all interventions will last 50 minutes and will be delivered twice a week for 6 weeks. to determine the effectiveness of the interventions, the primary outcome will assess pfc activity and cognition, and the secondary outcome will assess aerobic capacity, balance, upper extremity muscle strength, lower extremity muscle strength, and instrumental activities of daily living tasks. all assessments will be administered one week before and one week after the intervention.

Eligibility criteria:
inclusion criteria: * community-dwelling seniors age 65 and older * mmse-k 18 or less exclusion criteria: * people of hospitalized or institutionalized * people diagnosed with alzheimer's disease * people diagnosed with vascular dementia * people with musculoskeletal conditions that make physical activity difficult * people with dizziness that makes physical activity difficult * people with a wound or bleeding in the head

Keywords: cognitive-motor training cogntion physical function older adults interactive system wearable sensor
efficacy and safety study of oral cem-101 compared to oral levofloxacin in treatment of patients with community-acquired bacterial pneumonia

Conditions: Community-Acquired Bacterial Pneumonia

Summary: study to evaluate the safety and efficacy of oral cem-101 compared to oral levofloxacin in the treatment of adults with moderate to moderately severe community-acquired bacterial pneumonia.

community-acquired bacterial pneumonia is an acute infection of the pulmonary parenchyma with symptoms such as fever or hypothermia, chills, rigors, chest pain, and/or dyspnea. the widespread emergence of antibiotic resistant pathogens, including the macrolide-resistant streptococcus pneumoniae, has resulted in a need for new and effective antibiotics that have activity again cabp pathogens. cem-101 is the first fluoroketolide with excellent in vitro and in vivo activity against resistant s. pneumoniae and other key typical and atypical bacterial respiratory pathogens.

Eligibility criteria:
inclusion criteria: 1. diagnosis of community acquired bacterial pneumonia (e.g. cough with purulent sputum or change in character of sputum consistent with bacterial infection, dyspnea or tachypnea, chest pain due to pneumonia, fever, presence of rales and/or signs of consolidation). 2. no prior systemic antibacterial therapy, unless failed other therapy. 3. chest xray shows new lobar or multilobar infiltrate(s) consistent with acute bacterial pneumonia. 4. port risk class ii, iii, or iv \<=105 5. ability to take oral medication. exclusion criteria: 1. severe chronic obstructive pulmonary disease fev1 \<30%. 2. hospitalization within 90 days or residence in a long-term-care facility within 30 days prior to the onset of symptoms 3. chemotherapy or radiation therapy within the previous 3 months. 4. significant hepatic, hematological, renal abnormalities. 5. any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy and follow-up could be completed (e.g. life expectancy \<30 days).

Keywords: adults with community-acquired bacterial pneumonia
a cohort study (gut microbiota and hcc)

Conditions: Liver Cancer

Summary: to analyze the predictive role of intestinal microbiota in tyrosine kinase inhibitors (tkis) combined with immunotherapy response in patients with intermediate and advanced liver cancer.

this is a prospective, observational cohort study. patients with intermediate and advanced hepatocellular carcinoma who meet the enrollment and exclusion criteria are judged to be unresectable after evaluation by professional physicians, and are intended to be treated with anti-angiogenic targeted drugs combined with immune checkpoint inhibitors. during the treatment according to clinical needs, stool and blood samples were taken regularly, and the treatment response of patients was judged according to recist v1.1 criteria, and the common adverse reactions during treatment were evaluated by the ctcae5.0 grading system, and the relationship between intestinal microbiota and liver cancer treatment response was analyzed.

Eligibility criteria:
inclusion criteria: 1. age 18-75 years old, gender unlimited 2. diagnosed as hcc through pathological or clinical examination 3. bclc phase b or c 4. previously without systematic treatment 5. irremovable 6. intended to receive targeted anti-angiogenic drugs combined with immune checkpoint inhibitors for treatment 7. ≥ 1 measurable lesion (recist v1.1) 8. ecog ps 0-1 9. the subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up. exclusion criteria: 1. received attenuated live vaccine within 4 weeks prior to enrollment or planned during the study period 2. active, known or suspected autoimmune diseases 3. known history of primary immunodeficiency 4. known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation 5. pregnant or lactating female patients 6. uncontrolled concurrent diseases 7. currently conducting clinical trials for other drugs 8. other patients deemed unsuitable for inclusion by researchers
middle school to high school transition project: depression and substance abuse prevention

Conditions: Depression; Substance-Related Disorders

Summary: this study will implement a school-based program to prevent depression, academic failure, and substance use in at-risk adolescents transitioning from middle school to high school.

the transition from middle school to high school presents important challenges for adolescents. programs that enhance personal efficacy and social support resources may prevent at-risk students from developing behaviors that can lead to substance use, academic failure, and depression. this study will implement a skills-based program called coping and support training for the transition (cast-t) as a preventive intervention for at-risk students. at-risk students in eighth grade will be randomly assigned to receive either cast-t or school as usual. the cast-t program will initially be delivered in twelve sessions over 6 weeks in the middle school setting. the program includes booster sessions, case management, structured home-based parent education, and support and skills training throughout the transition period. participants will be assessed from the beginning of eighth grade to the end of ninth grade. vulnerability to academic problems and depression will be assessed with school records and self-report scale scores.

Eligibility criteria:
inclusion criteria: * at-risk for substance abuse, academic failure, and depression * enrolled in eighth grade in seattle public schools * english-speaking exclusion criteria: * score above the clinical cutoff on the youth self report aggressive subscale

Keywords: adolescent substance abuse at-risk
does heart rate variance (hrv) biofeedback help regulate emotions and improve mindfulness in mentally unwell offenders?

Conditions: Emotional Dysfunction

Summary: 14 participants residing in a forensic psychiatric hospital completed 15 heart rate variance (hrv) biofeedback sessions. they completed 4 psychometric questionnaires, pre, during and post biofeedback training.

this study aimed to establish whether heart rate variance (hrv) biofeedback improved hrv coherence as well as psychological well-being (depression, anxiety, emotion regulation, and mindfulness) over the course of 15 biofeedback sessions in a sample of 14 patients with varying diagnoses; paranoid schizophrenia, schizoaffective disorder, personality disorder or mixed diagnosis. all 14 participants (n=10 male, n=4 female) participated in 15 biofeedback sessions. the study was researched and treatment was facilitated by a trainee forensic psychologist working with both male and female offenders residing within a forensic psychiatric hospital, on both low and medium secure wards. an average coherence percentage was captured using the wild devine programme® relaxing rhythms software for each session. quantitative data were collected and analysed before, during and after biofeedback treatment to assess whether there was improvement in psychometric measures of depression, anxiety, emotion regulation and facets of mindfulness. a quasi experimental 'a-b-a design' was employed to assess the research questions.

Eligibility criteria:
inclusion criteria: * male and female offenders aged 18 and above. * male and female offenders who reside in a medium and low forensic psychiatric hospital. * individuals who have the capacity to consent to take part in the research * individuals deemed mentally stable and were found to have capacity to consent by their multi-disciplinary team (mdt). exclusion criteria: * individuals under the age of 18. * individuals who are not detained in a forensic psychiatric hospital. * individuals deemed not well enough to consent by their multi-disciplinary team (mdt). * a level of cognitive impairment determined by diagnosis that would prevent individuals from understanding the feedback obtained. via pictorial or verbal prompts * individuals with specific breathing difficulties (e.g., chronic obstructive pulmonary disease) that would restrict them from being able to practice the breathing techniques.

Keywords: biofeedback training, offenders, anxiety, depression
treadmill training with kinesiotaping affects balance and gait in chronic stroke patients

Conditions: Stroke

Summary: the goal of this clinical trial is to determine the effects of treadmill training with and without trunk kinesiotaping on balance and gait of chronic stroke patients. the main question it aims to answer is:- does kinesiotaping have added benefit to improve gait and balance in chronic stroke patients?. researcher will compare the treadmill training group with the group receiving treadmill training with kinesiotaping to see if there is any difference in the outcomes.

summary stroke, one of the leading cause of death and disability worldwide, is defined as rapid deterioration of brain function due to disturbance in blood supply to the brain. according to the cause it is divided into two main types; ischemic stroke and hemorrhagic stroke. stroke can lead to a number of physical impairments like muscle imbalance, impaired balance and postural control, poor voluntary control, body malalignment and disturbance of walking patterns etc. ability to walk safely and participate in activities of daily living is the main goal of many individuals affected by stroke. therefore, improving balance and gait is the primary focus of physical therapy interventions. many therapeutic interventions such as , treadmill training, over ground gait training , functional electrical stimulation, neurofacilitation approaches and strength training are used for improving balance and gait in patients affected by stroke, all of which have been proven to be beneficial. this study will be conducted to compare the effect of treadmill training with and without kinesiotaping on trunk muscles (rectus abdominis, erector spinae, external oblique and internal oblique) on gait and balance in chronic stroke patients. many studies have shown that trunk muscles have a very important role in balance and gait in patients with stroke and kt application may be an effective intervention for trunk function and postural control however, there is no evidence on whether providing support to the trunk with kinesiotaping during treadmill training will have any added benefit on balance and gait or not.

Eligibility criteria:
inclusion criteria: * both male and females * age 30-50 years. * duration of onset of stroke \>6 months. exclusion criteria: * • patients with orthopedic diseases(such as contracture) in the trunk and both lower extremities * a history of other neurologic diseases or disorders (ms, parkinsons). * history of fall in last 6 months.' * history of unstable cvs diseases * high skin sensitivity or skin diseases * lower extremity surgery or fracture, low back pain, or allergy to the kt.

Keywords: balance gait kinesiotape stroke
colloid improves organs function in resuscitation of extensive burn patients

Conditions: Burn

Summary: the present study was to evaluate the effectiveness of colloid compared with crystalloids for fluid resuscitation in critical burn patients with total burn surface area ≥50%.

extensive burn patients are some of the most challenging critically ill patients who may have multiple-system organ failure with life-threatening complications.over time, several resuscitation formulae have been proposed to guide burn resuscitation and the best known ones are parkland and evans formulae. the main controversy between the two formulae also focuses on whether to infuse the colloid in the first 24 h.controversy continues and the conflicting results left many clinicians unsure about the effect of colloids on fluid resuscitation in extensive burn patients who suffer higher risk of hypovolaemia, abdominal compartment syndrome (acs), multiple organs dysfunction and mortality. to address this uncertainty, we conducted a prospective, randomized, controlled clinical trial to compare fluid resuscitation in extensive burns guided by parkland formulae with tmmu formulae as a modified evans formula routinely used in china.

Eligibility criteria:
inclusion criteria: * burn patients with total burn surface area ≥50% and full thickness burn surface area ≥30%. exclusion criteria: * age \ 4 h, time arriving at our burn centre \> 6 h, pre-existing medical illnesses compromising the cardiopulmonary reserve or those need for compassionate care only.

Keywords: fluid resuscitation burn colloid, multiple organ dysfunction intra-abdominal pressure
continuous heparin infusion to prevent catheter-related thrombosis

Conditions: Cardiac Surgery; Central Venous Catheter Thrombosis; Heparin

Summary: catheter-related thrombosis could impair blood flow in the vein, block the central venous catheter, induce catheter-related infection or venous thromboembolism in the deep veins or pulmonary vessels, which furthermore progress into the post-thrombotic syndrome. researches using echogenic mass as the primary outcome could miss those premature thrombi which might not be seen on traditional ultrasonography but may be detected by duplex and doppler ultrasound with vessel compression. moreover, studies indicated that some thrombus developed after the catheter removal. removal of the catheter is not the endpoint of thrombus detection. this study is designed to determine the preventive effects of continuous heparin infusion on real-world central venous catheter-related thrombosis in infants after cardiac surgery.

catheter-related thrombosis could impair blood flow in the vein, block the central venous catheter, induce catheter-related infection or venous thromboembolism in the deep veins or pulmonary vessels, which furthermore progress into the post-thrombotic syndrome. researches using echogenic mass as the primary outcome could miss those premature thrombi which might not be seen on traditional ultrasonography but may be detected by duplex and doppler ultrasound with vessel compression. moreover, studies indicated that some thrombus developed after the catheter removal. removal of the catheter is not the endpoint of thrombus detection. this study is designed to determine the preventive effects of continuous heparin infusion on real-world central venous catheter-related thrombosis in infants after cardiac surgery. one hundred and twenty-four infants were randomized to the intervention group or the control group. unfractionated heparin or normal saline was infused continuously through each lumen of the central venous catheter at the speed of 0.5 ml/h/line until the catheter was removed. catheter-related thrombosis was detected by point-of-care duplex and doppler ultrasound periodically until 30 days after the cardiac surgery or discharge, whichever comes first.

Eligibility criteria:
inclusion criteria: * less than 3 months of age at admission, post-cardiac surgery, with cvc indwelled exclusion criteria: * parents' refusal, requiring postoperative anticoagulant administration (extracorporeal membrane oxygenation support, prosthetic devices), the contradiction to heparin (coagulopathy or hypercoagulable state, platelet level less than 50000/dl, clinically significant bleeding tendency, allergy to heparin)
pascual (prostate assay specific clinical utility at launch) study

Conditions: Prostate Cancer

Summary: the main hypothesis of this study is to demonstrate that the use of the confirmmdx for prostate cancer test in previously biopsied patients improves urologists' patient management by reducing unnecessary repeat biopsies, attendant procedure costs, and potential adverse events in men being considered for a repeat procedure.

the results of the study will reveal the clinical utility of this test by analyzing the physicians' use of negative or positive assays compared to patients managed using soc methods without assay findings. the repeat biopsy rate at 12 months from study entry will be used for the primary endpoint analysis. all patients will be followed for 24 months from the date of the previous negative biopsy to evaluate an extended period of observation to track repeat biopsies and cancer detection. the primary objective of this study is to demonstrate a lower repeat biopsy rate by using the negative results of confirmmdx for prostate cancer in practice rather than current soc. all patients will have the tissue from their previous negative biopsy tested with the assay. only data from cases (informed of confirmmdx assay results) and controls (blinded of the confirmmdx assay result) patients with negative test results will be used for the primary objective.

Eligibility criteria:
inclusion criteria: * males aged 40 to 75 years old\* that underwent a previous cancer-negative prostate biopsy within 15 months and being considered for a repeat biopsy due to persistent or elevated cancer-risk factors * the previous negative prostate biopsy must have collected a minimum of 8 tissue cores and remaining ffpe tissue from all cores should be available for testing * minimum tissue volume criteria of 20 microns of prostate biopsy core tissue should be available (40 microns preferable) * the presence of hgpin (high-grade prostatic intraepithelial neoplasia), pia (proliferative inflammatory atrophy), or glandular inflammation reported in the first biopsy histopathology report is acceptable for entry. exclusion criteria: * prior diagnosis of prostate cancer or cellular atypia suspicious for cancer (asap) in a previous biopsy histology report. * patients being managed by active surveillance for low stage prostate cancer * men greater than 75 years old (generally not considered for repeat biopsy) * most recent biopsy was a saturation biopsy (\> 24 tissue cores). * tissue extracted using transurethral resection of the prostate (turp) procedures rather than standard patterned biopsy core extraction. * subjects who had been previously tested with confirmmdx.

Keywords: prostate cancer